GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor...
FDA Recall #D-0875-2022 — Class II — April 27, 2022
Product Description
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Reason for Recall
Failed Stability Specification
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
26,910 bottles
Distribution
Product was distributed nationwide, including Puerto Rico.
Code Information
Lot # S001132, exp. date July 2022 NDC # 43386-060-19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated